Evaluation of Novel Skin Tape Transcriptome Methods in Children With Atopic Dermatitis and Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- skin RNA sequence for (lesional (L) and non-lesional (NL)) Skin Tape Strips (STS)
研究概览
简要总结
This pilot study will evaluate new methods for the collection, storage, shipment, and RNA extraction of skin tape specimens from children with atopic dermatitis (AD) that will facilitate the multi-center SunBeam Birth Cohort study. Additionally, this pilot study will test new methods for the generation of whole transcriptome sequencing data from skin tape RNA and whether these data reflect the transcriptional state of the skin in health and disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide informed consent/assent.
- •Male or female, 4-12 years of age (prepuberty) inclusive at the time of consenting
- •Participant must be either:
- •Active atopic dermatitis with two areas of non-lesional AD within 5 cm of the measured lesional area within the same region.
- •.No personal history or current manifestations of AD, food allergy, asthma, allergic rhinitis, and no positive prick or blood testing for allergen (based on self-report); and no evidence of dry skin or other skin condition
排除标准
- •Unable to provide consent or comply with the protocol
- •Presence of any skin condition that might compromise the stratum corneum barrier in infants and young children (e.g., ichthyosis, psoriasis, extensive seborrheic dermatitis, scabies)
- •History of any skin reaction to tape, or adhesives
- •Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
- •Use of any topical product (e.g., emollient, topical corticosteroids, topical immunomodulatory agents, topical antibiotics) on the area(s) to be tested within 24 hours before the study visit.
结局指标
主要结局
skin RNA sequence for (lesional (L) and non-lesional (NL)) Skin Tape Strips (STS)
时间窗: through study completion, single visit with an average of 2 hours
the novel skin tape transcriptome method will extract RNA; the outcome is to identify the difference in RNA sequence between lesional and non-lesional skin.
次要结局
未报告次要终点